Oxygen Level and Safe Emergence From Anesthesia

NCT ID: NCT01779076

Last Updated: 2018-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-06-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Using a protective ventilation strategy during general anesthesia from pre-oxygenation to emergence and selecting patients without risk of a difficult airway or intubation, a lower fraction of inspiratory oxygen (FIO2) can be used during extubation. This might reduce the postoperative area of atelectasis without desaturations becoming more common.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Focus of Study is Postoperative Pulmonary Atelectacis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

100% oxygen during extubation

In this arm the intervention will consist of 100 % oxygen.

Group Type EXPERIMENTAL

100% oxygen

Intervention Type PROCEDURE

30% oxygen during extubation

In this arm the intervention will consist of 30 % oxygen.

Group Type EXPERIMENTAL

30% oxygen

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

30% oxygen

Intervention Type PROCEDURE

100% oxygen

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* No sign of difficult airway or intubation
* Day case surgery in total intravenous anesthesia with laryngeal mask airway without adding regional anesthesia of plexus brachialis or muscle relaxant.
* Body mass index less than 35.
* American Society of Anesthesiologists physical status (ASA) class I-III

Exclusion Criteria

* Body mass index 35 or higher
* Increased risk of aspiration
* Obstructive sleep apnea syndrome
* Procedures during surgery making a former easy airway a difficult airway
* Need for opioids after extubation
* Hypothermia
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Region Västmanland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lennart Edmark

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mats Enlund, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Landstinget i Värmland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Västmanlands sjukhus Köping

Köping, Västmanland County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Edmark L, Auner U, Lindback J, Enlund M, Hedenstierna G. Post-operative atelectasis - a randomised trial investigating a ventilatory strategy and low oxygen fraction during recovery. Acta Anaesthesiol Scand. 2014 Jul;58(6):681-8. doi: 10.1111/aas.12322. Epub 2014 Apr 11.

Reference Type DERIVED
PMID: 24720763 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Dnr 2012 / 539

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Perioperative UtiLisation of SupplEmental Oxygen
NCT03552627 ACTIVE_NOT_RECRUITING PHASE4